Nov 20, 2008 Thursday 13:00:46 Human Subjects Research Principles & Declarations Regulations Education Forms & Certification Registration Key Agencies Role of the Institution HSCs: IRBs & IECs Principal Investigators & Researchers BioEthics IACUC, BioSafety & Radiation Safety Search Related Sites: Health Resources Health Topics AIDS Primer Cancer Resources Heart Diseases & Stroke Medical Centers Nutrition & Metabolism Science & Technology The Scientist Reference Desk Treasures of the Internet

Institutional Review Board (IRB) Visit also the Bioethics website and use the health and science-focused Search engines and directories section to find additional information about the topics listed below. Title 45 Public Welfare -- Subtitle A -- DHHS -- Part 46 -- Protection of Human Subjects29 Text PDF 45.46.101 To what does this policy apply? 29 Text PDF 45.46.102 Definitions. 29 Text PDF 45.46.103 Assuring compliance with this policy--research conducted or supported by any Federal Department or Agency.29 Text PDF 45.46.107 IRB membership.29 Text PDF 45.46.108 IRB functions and operations.29 Text PDF 45.46.109 IRB review of research.29 Text PDF 45.46.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.29 Text PDF 45.46.111 Criteria for IRB approval of research.29 Text PDF 45.46.112 Review by institution.29 Text PDF 45.46.113 Suspension or termination of IRB approval of research.29 Text PDF 45.46.114 Cooperative research.29 Text PDF 45.46.115 IRB records. 29 Text PDF 45.46.116 General requirements for informed consent. 29 Text PDF 45.46.117 Documentation of informed consent.29 Text PDF 45.46.118 Applications and proposals lacking definite plans for involvement of human subjects.29 Text PDF 45.46.119 Research undertaken without the intention of involving human subjects.29 Text PDF 45.46.120 Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal Department or Agency.29 Text PDF 45.46.122 Use of Federal funds.29 Text PDF 45.46.123 Early termination of research support: Evaluation of applications and proposals.29 Text PDF 45.46.124 Conditions.29 Text PDF 45.46.201 Applicability. 29 Text PDF 45.46.202 Purpose. 29 Text PDF 45.46.203 Definitions. 29 Text PDF 45.46.204 Ethical Advisory Boards. 29 Text PDF 45.46.205 Additional duties of the Institutional Review Boards in connection with activities involving fetuses, pregnant women, or human in vitro fertilization. 29 Text PDF 45.46.206 General limitations. 29 Text PDF 45.46.207 Activities directed toward pregnant women as subjects. 29 Text PDF 45.46.208 Activities directed toward fetuses in utero as subjects. 29 Text PDF 45.46.209 Activities directed toward fetuses ex utero, including nonviable fetuses, as subjects. 29 Text PDF 45.46.210 Activities involving the dead fetus, fetal material, or the placenta. 29 Text PDF 45.46.211 Modification or waiver of specific requirements. 29 Text PDF 45.46.301 Applicability. 29 Text PDF 45.46.302 Purpose. 29 Text PDF 45.46.303 Definitions. 29 Text PDF 45.46.304 Composition of Institutional Review Boards where prisoners are involved.29 Text PDF 45.46.305 Additional duties of the Institutional Review Boards where prisoners are involved.29 Text PDF 45.46.306 Permitted research involving prisoners.29 Text PDF 45.46.401 To what do these regulations apply?29 Text PDF 45.46.402 Definitions.29 Text PDF 45.46.403 IRB duties.29 Text PDF 45.46.404 Research not involving greater than minimal risk.29 Text PDF 45.46.405 Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects.29 Text PDF 45.46.406 Research involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject's disorder or condition.29 Text PDF 45.46.407 Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.29 Text PDF 45.46.408 Requirements for permission by parents or guardians and for assent by children. 29 Text PDF 45.46.409 Wards. 29 see also Institutional Review Boards Visit the Federal Register and use the search section to obtain recent updates of 21.56 & 45.46. ___________ Notes and Footnotes: Click on Literature Sources to access the source of the information database, specified as superscript after each topic link.

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First Written: 19990118 Latest Update: 20060328

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